QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant (ReGIFT)

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The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from donors >45 years after brain death (DBD).

Condition or disease

Intervention/treatment

Phase

Delayed Graft Function

Drug: QPI-1002Other: Placebo

Phase 3

Detailed Description:

This is a Phase 3 randomized, placebo-controlled, double-blind, multi-center trial stratified by donor age and by region to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from DBD donors who were at least 45 years of age.

A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Has the ability to understand the requirements of the study, is able to provide written informed consent and is willing and able to comply with the requirements of the study protocol.

Is able to comply with the requirement of antibody induction therapy with rabbit polyclonal anti-thymocyte globulin or anti-CD25 (anti-IL2R) monoclonal antibodies per center standard of care.

Must be up-to-date on cancer screening according to site-specific guidelines and past medical history must be negative for biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ or carcinoma of the cervix in situ.

Exclusion Criteria:

Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor.

Has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant).

Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.

Has lost first kidney transplant due to graft thrombosis.

Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy under another IND/CTA for ischemic/reperfusion injury immediately prior to organ recovery.

Is scheduled to receive an ABO-incompatible donor kidney.

Has a positive T- or B-cell cross-match by NIH anti-globulin lymphocytotoxicity method or CDC crossmatch method, if performed.

Has a positive T- or B-cell flow cross-match AND donor specific anti-HLA antibody (DSA) detected by flow cytometry, Luminex® based antigen-specific anti-HLA antibody testing, or by similar methodology, if performed.

Has participated in an investigational study within the last 30 days or received an investigational product within 5 half-lives of the study drug administration, whichever is longest.

Has known allergy to or has participated in a prior study with siRNA.

Has a history of HBV (Note: subjects with a serological profile suggestive of clearance, or prior antiviral treatment of a prior HBV infection, may be enrolled with the approval of the Medical Monitor).

Has a history of HIV.

Recipient of a known HIV positive donor kidney.

Is HCV-positive (detectable HCV RNA) (Note: Subjects at least 24 weeks from completion of treatment with an approved antiviral regimen and who remain free of HCV as determined by HCV RNA testing may be enrolled. Subjects who have been cleared of HCV virus after treatment with an unapproved regimen should be approved by the Medical Monitor).